Reported Jul 16, 2025 · Ongoing
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- VersaCross Access Solution (VXSK)
- Product Description and IDVXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1) VXSK0122 VXSK (180P RF WIRE 63CM/55DEG/D0) VXSK0123 VXSK (180P RF WIRE 63CM/55DEG/D1) VXSK0124 VXSK (180P RF WIRE 63CM/90DEG/D0) VXSK0125 VXSK (230J RF WIRE 63CM/45DEG/D0) VXSK0111 VXSK (230J RF WIRE 63CM/45DEG/D1) VXSK0112 VXSK (230P RF WIRE 63CM/45DEG/D0) VXSK0131 VXSK (230P RF WIRE 63CM/45DEG/D1) VXSK0132 VXSK (230P RF WIRE 63CM/55DEG/D0) VXSK0133 VXSK (230P RF WIRE 63CM/55DEG/D1) VXSK0134 VXSK (230P RF WIRE 81CM/45DEG/D0) VXSK0137 VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0021 VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0022 VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0024 VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH VXSK0025 VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0031 VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0032 VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0034
- Lot codes and dates
21 of 21 products
Products covered by this recall # Barcodes Product as published 1 00685447011729VXSK0021 UDI-DI 00685447011729 Lots 35590858 35607785 35627540 2 0068544701173600685447011750VXSK0022 UDI-DI 00685447011736 Lots 35487923 35544014 35552652 35566071 35595443 35604160 35616857 VXSK0024 UDI-DI 00685447011750 Lot 35576278 3 00685447011767VXSK0025 UDI-DI 00685447011767 Lot 35582041 4 00685447011828VXSK0031 UDI-DI 00685447011828 Lots 35499536 35627156 5 00685447011835VXSK0032 UDI-DI 00685447011835 Lots 35508294 35518904 35563958 35582043 35635451 6 00685447011859VXSK0034 UDI-DI 00685447011859 Lots 35573519 35593310 7 00685447019749VXSK0101 UDI-DI 00685447019749 Lot 35893570 8 00685447019756VXSK0102 UDI-DI 00685447019756 Lot 35720571 9 00685447019763VXSK0103 UDI-DI 00685447019763 Lot 36042383 10 00685447019794VXSK0111 UDI-DI 00685447019794 Lot 35944186 11 00685447019800VXSK0112 UDI-DI 00685447019800 Lot 36061050 12 00685447019817VXSK0121 UDI-DI 00685447019817 Lots 35745702 35787463 13 00685447019824VXSK0122 UDI-DI 00685447019824 Lots 35699501 35720572 35768613 35780309 35790937 35830237 35833400 14 00685447019831VXSK0123 UDI-DI 00685447019831 Lot 35843757 15 00685447019848VXSK0124 UDI-DI 00685447019848 Lots 35697863 35883199 16 00685447019855VXSK0125 UDI-DI 00685447019855 Lot 35859706 17 00685447019862VXSK0131 UDI-DI 00685447019862 Lots 35729751 35807530 35900608 18 00685447019879VXSK0132 UDI-DI 00685447019879 Lots 35695371 35729750 35807531 35910367 35955008 19 00685447019886VXSK0133 UDI-DI 00685447019886 Lot 35839894 20 00685447019893VXSK0134 UDI-DI 00685447019893 Lot 35666909 - Amount recalled
- 14,724
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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